For many patients in Intensive Care Units (“ICUs”), an endotracheal tube is the only lifeline that connects the ICU patient to a critical supply of oxygen. If an endotracheal tube becomes dislodged or is accidentally removed, the patient only has mere moments for the endotracheal tube to be replaced before the damaging effects of hypoxia start to occur. If the patient is accidentally extubated and no healthcare professional is cognizant of the situation, the patient could die within minutes as a result of cerebral hypoxia. Thus, it is a matter of life and death that the endotracheal tube remains securely in place to maintain consistent and reliable oxygen delivery.
A bridling system is presently used with feeding tubes, as described in U.S. Pat. No. 7,534,228 to Williams, entitled “Bridle Catheter with Umbilical Tape,” the disclosure of which is incorporated herein by reference in its entirety. Williams discloses a device that uses a flexible member 2 with a magnet 4 attached to one end of the flexible member 2 and an umbilical tape 6 attached to the flexible member 2. The flexible member 2 is inserted into a first naris 8 of a patient's nose 10 using an insertion tool 12 which makes the flexible member 2 stiff enough to be inserted into the nasal cavity. A retrieving tool 14 having a magnetic end 4 is inserted into a second naris 16 of the patient's nose 10 and couples with the magnet 4 of the flexible member 2. Once the retrieving tool 14 and the flexible member 2 are coupled magnetically behind the posterior nasal septum of the patient 24, the retrieving tool 14 is pulled out of the second naris 16 and the flexible member 2 follows around the vomer bone and out the second naris 16, pulling the umbilical tape 6 with it. The flexible member 2 is pulled entirely out of the second naris 16, leaving the umbilical tape 6 in position behind the vomer bone.
The Williams bridling system uses a flexible tape 6 that is inserted behind the vomer bone in the patient's nose 10 so that a portion of the tape 6 extends from each naris 8, 16 and is coupled to a feeding tube to hold the feeding tube in place. The feeding tube is clipped to the tape 6 (also known as a “bridle”). The patient is deterred from removing the feeding tube because pulling on the feeding tube will result in pulling on the tape 6. Because of the position of the tape 6 behind the vomer bone, pulling on the tape 6 will cause the patient pain or discomfort. In this manner, a patient is deterred from removing the feeding tube. The use of an umbilical tape 6 provides other important benefits, as described in the Williams patent.
A number of endotracheal tube anchoring devices are presently available in the healthcare market. These often require that adhesive tape be applied to a patient's face or involve some sort of stabilizing component to rest against a patient's face. One drawback to adhesive use is that adhesive applied to the skin may cause the skin to break down, which can cause patient discomfort and lead to infection. If the retention of the endotracheal tube is dependent upon adhesive, the adhesive may also break down resulting in failure of the system. In addition, stabilizers positioned against a patient's skin may result in skin ulcers or other complications. The use of adhesive and stabilizers is contradicted in the case of burn patients. There is a need in the medical field for a device that can assist in consistently retaining an endotracheal tube within a patient's airway without the use of stabilizers or adhesive.